Novel Electronic Monitoring Devices (NEMD) to Monitor Adherence in Children With Asthma

NCT04289714 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-10-27

Study results available
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Summary

This is a feasibility study to assess novel electronic monitoring devices for monitoring adherence in children with asthma who are on inhaled corticosteroids (ICS)

It is a mixed method (quantitative and qualitative) open label, pragmatic randomised feasibility study with two main aims:

1. To assess the feasibility of 4 novel electronic monitoring devices in children aged 6-16 years with asthma, in terms of usability and acceptability by patients/ guardians and healthcare professionals (qualitative study)
2. To evaluate the accuracy of these devices and assess whether they impact on asthma control (quantitative study).

The duration of study is 16 weeks.

Conditions

  • Asthma in Children

Interventions

DEVICE

Novel Electronic Monitoring Device

Four Novel electronic Monitoring Devices were trialled

Sponsors & Collaborators

  • Asthma UK

    collaborator OTHER
  • Imperial College London

    lead OTHER

Principal Investigators

  • Louise Fleming, MD · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-12
Primary Completion
2019-05-18
Completion
2019-05-18

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04289714 on ClinicalTrials.gov